What will the FDA do about peptides?
Last week, MAHA proudly announced that the FDA Panel appointed by HHS Secretary Robert F. Kennedy Jr had approved 6 of 7 Peptides over the objections of FDA scientists.
The vote is a win for HHS Secretary Kennedy and MAHA, opening a path for compounding pharmacies to prepare BPC-157, TB-500 and four other popular peptides by prescription.”
The vote was close: RFK Jr’s personal appointees outnumbered FDA scientists concerned that the peptides have not been shown to be safe or effective.
RFK Jr believes in peptides and loaded the panel with his appointees; six of his eight appointees sell peptides.
The FDA raised concerns about conflicts of interest, but to no avail.
This panel is strictly advisory. The FDA does not have to accept its recommendations.
The big question: Will the FDA accept this recommendation or reject it?
- If the acting head of FDA, Kyle Diamantas, accepts the panel’s recommendation, it will be a political, not scientific, decision.
- If he rejects the panel’s recommendation, he risks losing his job.
At stake: the FDA’s role as a science-based regulatory agency.
Principles anyone?
What this is about
Peptides are small proteins (50 or fewer amino acids), some of which have regulatory actions in the body. The best examples are GLP-1 drugs.
They have to be injected; if swallowed as pills, they would be destroyed by digestive enzymes.
For what this is about, see the excellent account in the New Yorker: Why Are People Injecting Themselves with Peptides?
The ones just approved by the FDA committee are claimed (without much in the way of evidence) to do fabulous things for health.
Peptide sellers have pushed hard for the FDA to approve them.
Comment
There is plenty of anecdotal evidence for the benefits of injected peptides, but no real science.
Peptides are in a regulatory limbo. Supplements are virtually unregulated as a result of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Consequently, you have no way of knowing if you are getting what the label says you are getting.
But peptides are injected, and not regulated under DSHEA. That’s what this committee is trying to fix.
Caveat emptor!
I can’t wait to see what Diamantas does on this and what happens to him if he does the right thing and rejects the panel’s recommendations.
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